A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD1390 (NSC# 852149) When Combined With Focal Radiation in Pediatric Patients With High Grade Glioma
Children's Oncology Group
Summary
This phase I clinical trial studies the side effects and best dose of AZD1390 and to see how well it works when given together with radiation therapy for the treatment of pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma. AZD1390 is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving AZD1390 with radiation may be safe, tolerable, and/or effective in treating pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma.
Description
PRIMARY OBJECTIVES: I. To define the recommended phase 2 dose of ATM Kinase Inhibitor AZD1390 (AZD1390) when given in combination with radiation for pediatric supratentorial high-grade gliomas. II. To define the recommended phase 2 dose of AZD1390 when given in combination with radiation for pediatric infratentorial high-grade gliomas. III. To define the toxicities and characterize the safety profile of AZD1390 when given in combination with radiation for pediatric supratentorial high-grade gliomas. IV. To define the toxicities and characterize the safety profile of AZD1390 when given in c…
Eligibility
- Age range
- 1–22 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * COHORT A and COHORT B: For the dose escalation phase, patients must be ≥ 12 months and \< 18 years of age at the time of study enrollment * COHORT C and COHORT D: For the disease expansion phase, patients must be ≥ 12 months and \< 22 years of age at the time of study enrollment * Patients with newly diagnosed primary high-grade glioma (HGG), diffuse midline glioma (DMG) (excluding primary spinal tumors), or diffuse intrinsic pontine glioma (DIPG) who are eligible to receive 54-59.4 grey (Gy) fractionated radiation at 1.8 Gy/day. Patients must have had histologic verific…
Interventions
- DrugATM Kinase Inhibitor AZD1390
Given PO
- ProcedureBiospecimen Collection
Undergo blood and cerebrospinal fluid collection
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- RadiationRadiation Therapy
Undergo radiation therapy
- OtherSurvey Administration
Ancillary studies
Locations (20)
- Children's Hospital of AlabamaBirmingham, Alabama
- Children's Hospital Los AngelesLos Angeles, California
- Children's Hospital of Orange CountyOrange, California
- UCSF Medical Center-Mission BaySan Francisco, California
- Children's Hospital ColoradoAurora, Colorado
- Children's National Medical CenterWashington D.C., District of Columbia